Ultraverse® 035 PTA Dilatation Catheter U357588Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741093975), received between Dec 6, 2016 and Apr 23, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD A HOLE IN IT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887640 ↗
• MalfunctionJul 3, 2023Burst Container or Vessel; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE ENTIRE SHAFT OF THE PTA BALLOON ALLEGEDLY EXPLODED DUE TO OVER-INFLATION. IT WAS FURTHER REPORTED THAT THE PTA BALLOON AND THE BROKEN PARTS WERE REMOVED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17253199 ↗
• MalfunctionDec 16, 2022Difficult to Insert; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Difficult to Insert; Difficult to Remove; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN BRACHIAL VEIN VIA LEFT LOWER ARM, THE PTA BALLOON DILATATION CATHETER ALLEGEDLY STUCK ENTIRELY IN THE SHEATH. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD DIFFICULTY IN REMOVING THROUGH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15993763 ↗
• InjuryApr 7, 2021Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT BALLOON FRAGMENTS ARE ALLEGEDLY DETACHED FORM BALLOON AND LEFT ON PATIENT AND HAD DIFFICULT TO REMOVE BALLOON FROM THE SHEATH. REPORTEDLY ADDITIONAL INTERVENTION REQUIRED TO REMOVE THE SEGMENTS FORM THE PATIENT. PATIENT STATUS WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11625896 ↗
• MalfunctionDec 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11035887 ↗
• InjuryAug 17, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THROUGH A POST-DILATATION PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. THE HCP WITHDREW THE DEVICE WITH DIFFICULTY, ELONGATION OF THE SHAFT AND DISTAL PART OF THE PTA WAS MISSED. REPORTEDLY A CIRCUMFERENTIAL RUPTURE WAS NOTICED THAT MAKES THE WAY OUT VERY DIFFICULT, SO A PART OF THE BALLOON WAS GRASPED WHILE PERFORMING A THROMBO-EMBOLECTOMY. OTHERWISE, THIS PART COULD HAVE MIGRATED LOWER IN THE LEG, CAUSING EMBOLISM AND ISCHEMIA. THE PATIENT WAS HOSPITALIZED.

  Patient problems: Embolism

  MAUDE report 10412789 ↗
• InjuryApr 5, 2017Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE BRACHIOCEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 7ATM. IT WAS FURTHER REPORTED THAT DURING RETRACTION, A SEGMENT OF THE BALLOON CATHETER AND THE DISTAL RADIOPAQUE MARKER WAS ALLEGEDLY STUCK ON A STRUT OF A STENT AND DETACHED IN THE PATIENT. AFTER MULTIPLE ATTEMPTS TO RETRIEVE THE RADIOPAQUE MARKER AND BALLOON SEGMENT WITH A SNARE DEVICE, THE DECISION WAS MADE TO REMOVE THE MARKER AND BALLOON SEGMENT AT A LATER TIME. THE PROCEDURE WAS COMPLETED WITH THE USE OF A PURSE STRING SUTURE AT THE ACCESS SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6461399 ↗
• InjuryDec 6, 2016Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT THE DURING THE SECOND INFLATION, THE PTA BALLOON CATHETER ALLEGEDLY RUPTURED AT 16 ATM IN A A/V GRAFT FISTULA. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER (HCP) WAS UNABLE TO REMOVE THE BALLOON FROM THE VESSEL AFTER SEVERAL ALLEGED ATTEMPTS. THE HCP PERFORMED A CUT DOWN ON THE VESSEL AND REMOVED THE BALLOON. THE HCP PERFORMED A THROMBECTOMY AND ESTABLISHED PATENCY OF THE VESSEL WITH GOOD FLOW. THE PATIENT WAS REPORTEDLY DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6149612 ↗